0    OBJECTIVE

         The objective of this document is to provide the procedure for operating and cleaning of blister Change parts.

2.0   SCOPE

        This Standard Operating Procedure is applicable for operating and cleaning of blister change part.

3.0   RESPONSIBILITY

3.1      All Production Officer / Chemist and operators are responsible to follow this standard operating Procedure.

3.2      Quality assurance is responsible for the compliance of this standard operating procedure.

3.3      Head Production is responsible for the implementation of this standard operating procedure.

4.0   ACCOUNTIBILITY

                 Head – Production  

5.0   Procedure

• Operating Procedure :

5.1.1 Check and ensure that blister change parts are “CLEANED”.

5.1.2 Take the particular blister change parts from the rack to the blister area as per requirement in presence of packing supervisor.

5.1.3 Recognize the blister change parts according to their I.D. No. which is mentioned on the rack.

5.1.4 Check and ensure the blister change parts I.D.

5.1.5 Record in blister change parts issuing log book.

5.1.6 Load the change part to the blister as per specified in batch packing record.

5.1.7 After completion of the batch unload the blister change parts and keep specified place with the status label  duly  filled and signed by competent technical staff.

5.1.8 Return the blister change parts and maintain the record.

5.2 Cleaning Procedure:

5.2.1 Take the blister change parts to the washing area.

5.2.2 Clean the blister change parts through dry, cotton lint free cloth with 70% IPA.

5.2.3 Remove the previous product / batch identity from the blister change parts.

5.2.4 Clean the blister change parts with the help of compressed air.

5.2.5 Transfer the blister change parts to the blister area.

5.2.6 Affix the status label “CLEANED” to the blister change duly filled and signed by competent technical staff.

5.2.7 Put the blister change parts in designated rack.

6.0       TRAINING

Trainer   : Head – Quality Assurance

 Trainees : Production staff, Operator & QA   

7.0       DISTRIBUTION

Master Copy                      :           Quality Assurance

Controlled Copy                :           Production Department

Display Copy                    :           Production Department (If Required)

 8.0      ATTACHMENTS

Sr. No.	Annexure No.	Title	Format No.
1	NA	NA	NA

•       REFERENCES          

      In-house

10.0     ABBREVIATION

Abbreviation	Extended Form
EG	Engineering
SOP	Standard Operating Procedure
QA	Quality Assurance
WH	Warehouse
NA	Not Applicable
MB	Microbiology

11.0       REVISION HISTORY OF CHANGE

Sr. No.	Date	Revision Details	Revision No.